Product Safety Recalls

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Acumed LLC Recall 89771

Description: 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010

Acumed LLC Recall 89771 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0958-2022
Event ID89771
Event Description4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, Puerto Rico and the country of South Africa.
Quantity537 units
Recall ReasonCannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage.
Device Classification20220427
Device Code InfoAll Batch number distributed between 22 AUG 2018 to 07 FEB 2022 . UDI : 10806378022869
Center Classification Date20220420
Recall Initiation Date20220309
Recalling FirmAcumed LLC
Initial Notification Letter
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